Reported Jun 19, 2019 · Terminated
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI…
Terumo Cardiovascular Systems Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Cardiovascular Systems Corporation · 6200 Jackson Rd · Ann Arbor, MI · 48103-9586
Is this the product you have?
- Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
- Lot codes and dates
- Lot/Serial
013380133901340013410134201349013500135101352013530135401355013560135701358013600136101362013630136501366013670136901370013710137201373013740137501376013770137801379
Lot/Serial013800138101382013830138401385013860138701388013890139401395013960139701398014050140601407014080141001411014130141401415014160141801420014210142201423014240142501426
UDI 0088679900058801427014280142901430014310143201434014351718231744179999
- Amount recalled
- 72
Where it was sold
Why it was recalled
An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled by the local control knobs.
This product could cause temporary or reversible health problems — stop using it.
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